The U.S. Food and Drug Administration (FDA) today allowed marketing of the DEKA Arm System, the first prosthetic arm that can perform multiple, simultaneous powered movements controlled by electrical signals from electromyogram (EMG) electrodes.
Category Archives: Drug Safety Information Podcasts
FDA approves Zontivity to reduce the risk of heart attacks and stroke in high-risk patients
The U.S. Food and Drug Administration today approved Zontivity (vorapaxar) tablets to reduce the risk of heart attack, stroke, cardiovascular death, and need for procedures to restore the blood flow to the heart in patients with a previous heart attack or blockages in the arteries to the legs.
United States enters consent decree with New York cheese producer due to Listeria contamination
On April 28, 2014, United States District Court Judge Richard J. Arcara of the Western District of New York entered a consent decree of permanent injunction between the United States and Finger Lakes Farmstead Cheese Company, LLC, of Trumansburg, N.Y. and its co-owner Nancy Taber Richards. The consent decree was pursued by the U.S. Attorney’s Office for the Western District of New York on behalf of the U.S. Food and Drug Administration.
FDA issues proposals to address risks associated with surgical mesh for transvaginal repair of pelvic organ prolapse
The U.S. Food and Drug Administration today issued two proposed orders to address the health risks associated with surgical mesh used for transvaginal repair of pelvic organ prolapse (POP). If finalized, the orders would reclassify surgical mesh for transvaginal POP from a moderate-risk device (class II) to a high-risk device (class III) and require manufacturers to submit a premarket approval (PMA) application for the agency to evaluate safety and effectiveness.
FDA approves Zykadia for late-stage lung cancer
The U.S. Food and Drug Administration today granted accelerated approval to Zykadia (ceritinib) for patients with a certain type of late-stage (metastatic) non-small cell lung cancer (NSCLC).
FDA approves first human papillomavirus test for primary cervical cancer screening
The U.S. Food and Drug Administration today approved the first FDA-approved HPV DNA test for women 25 and older that can be used alone to help a health care professional assess the need for a woman to undergo additional diagnostic testing for cervical cancer. The test also can provide information about the patient’s risk for developing cervical cancer in the future.
FDA approves Sylvant for rare Castleman’s disease
The U.S. Food and Drug Administration today approved Sylvant (siltuximab) to treat patients with multicentric Castleman’s disease (MCD), a rare disorder similar to lymphoma (cancer of the lymph nodes).
FDA proposes to extend its tobacco authority to additional tobacco products, including e-cigarettes
As part of its implementation of the Family Smoking Prevention and Tobacco Control Act signed by the President in 2009, the U.S. Food and Drug Administration today proposed a new rule that would extend the agency’s tobacco authority to cover additional tobacco products.
FDA proposes new expedited access program for medical devices that address unmet medical needs
Today, the U.S. Food and Drug Administration proposed a new program to provide earlier access to high-risk medical devices that are intended to treat or diagnose patients with serious conditions whose medical needs are unmet by current technology.
FDA approves Cyramza for stomach cancer
The U.S. Food and Drug Administration today approved Cyramza (ramucirumab) to treat patients with advanced stomach cancer or gastroesophageal junction adenocarcinoma, a form of cancer located in the region where the esophagus joins the stomach.